K-ASSAY® Transferrin Reagent (L) KAI-101
GUDID 00816426020382
For the quantitative determination of human transferrin in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
Transferrin IVD, reagent| Primary Device ID | 00816426020382 |
| NIH Device Record Key | 8b6400bc-f669-4868-8c09-e5ba99398c47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-ASSAY® Transferrin Reagent (L) |
| Version Model Number | KAI-101 |
| Catalog Number | KAI-101 |
| Company DUNS | 197934250 |
| Company Name | KAMIYA BIOMEDICAL COMPANY, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816426020382 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993537
FDA Product Code
| DDG | Transferrin, Antigen, Antiserum, Control |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
Devices Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC
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| 00816426021679 - K-ASSAY® hsCRP Control | 2021-03-09 For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP). |
| 00816426021631 - K-ASSAY® Apo AI / B Control | 2021-01-05 For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B. |
| 00816426021648 - K-ASSAY® Apo AI / B Control | 2021-01-05 For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B. |
| 00816426020894 - K-ASSAY® Plasma Control | 2019-12-27 For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. |
| 00816426021129 - K-ASSAY® Factor XIII Control | 2019-12-27 For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII. |
| 00816426021396 - K-ASSAY® UIBC Reagent | 2019-04-17 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. |
| 00816426021402 - K-ASSAY® UIBC Reagent (L) | 2019-04-17 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. |
Trademark Results [K-ASSAY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K-ASSAY 75060842 2045784 Live/Registered |
KAMIYA BIOMEDICAL COMPANY, LLC 1996-02-22 |
 K-ASSAY 74707766 2011686 Live/Registered |
KAMIYA BIOMEDICAL COMPANY, LLC 1995-07-28 |
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